Safety and Efficacy of AON-D21 in Severe Community-Acquired Pneumonia.

Completed · Phase 2 · Has a placebo group

Conditions studied: Community-acquired Pneumonia

In brief

The goal of this clinical trial is to compare the safety and efficacy of AON-D21 versus placebo, both on top of standard of care, in patients with severe community acquired pneumonia admitted to ICU (or similar unit). The main questions to answer are: * The safety and tolerability of AON-D21 vs placebo. * The efficacy of AON-D21vs placebo. * The pharmacokinetics of AON-D21. * The pharmacodynamics of AON D21. * To identify biomarkers for patient stratification and analyses in future trials.

Key facts

Study ID: NCT05962606
Run by: Aptarion Biotech AG
People needed: 150
Starts: 2024-02-02
Expected to finish: 2026-03-16
Last updated by the study team: 2026-03-18

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Community-acquired pneumonia, confirmed or suspected of bacterial or viral origin.
Admitted to an ICU (or similar unit).
Requiring respiratory support by HFO ≥ 30 L/min with FiO2 ≥ 30% or NIV or IMV or ECMO.
CRP ≥ 50 mg/L.
PaO2/FiO2 ratio ≤ 150 mmHg.
Treatment initiation no more than 48 h after initiation of respiratory support (HFO ≥ 30 L/min with FiO2 ≥ 30%, NIV, IMV or ECMO).
Written informed consent.
Age ≥ 18 years to ≤ 85 years.
Body mass index ≥ 17.5 kg/m² and ≤ 40 kg/m².
For female participants of childbearing potential, agreement to use dual methods of contraception until Day 60.
For male participants with female partners of childbearing potential, agreement to use barrier method of contraception until Day 60 and to refrain from donating sperm during the study and for 3 months after the last infusion.

You may not qualify if…

Refractory septic shock.
Not expected to survive 72 hours.
Hospital-acquired or ventilator-associated pneumonia or known or suspected pneumonia due to aspiration or other physical injury or trauma or tuberculosis.
Known or suspected hypersensitivity to AON-D21 or any components of the formulation used (e.g., PEG, mannitol or EDTA) or a history of clinically relevant allergy requiring continuous treatment, or of anaphylaxis.
Known fibrotic lung disease, bronchiectasis or any other known severe chronic respiratory disease.
Active malignant disease.
Factors other than a pathogen suspected or confirmed to be causative for the respiratory insufficiency.
Hepatocellular injury defined by an ALT or AST value ≥ 3 times the ULN. Known acute or chronic liver disease with Child-Pugh C (See Appendix 13.6.2).
Any medical disease or condition that, in the opinion of the investigator(s), compromises the participant's safety or compromises the interpretation of the results.
Receiving chronic immunosuppressive therapy in relevant doses.
Known immunodeficiency disease/condition.
Nursing and pregnant women (defined as the state after conception until the termination of gestation, screened in all women of child-bearing potential with a chorionic gonadotrophin (hCG) blood test (local laboratory).
Current or recent participation in an investigational trial.
Systemic treatment with any complement inhibitor.
Known complement deficiency.
Unlikely to remain at the investigational site beyond 96 h.

Where it is running

Nouvel Hôpital Civil — Strasbourg, France
CHRU de Tours Hôpital Bretonneau — Tours, France
Hôpital Nord Franche Comté — Trévenans, France
University of Alabama at Birmingham Heersink School of Medicine — Birmingham, Alabama, United States
Cliniques Universitaires Saint-Luc — Brussels, Belgium
Clinique Saint Pierre — Ottignies, Belgium
Centre Hospitalier Argenteuil — Argenteuil, France
Centre Hospitalier Départemental Vendée — La Roche-sur-Yon, France
CHU Dupuytren — Limoges, France
Centre Hospitalier de Melun — Melun, France
Hotel Dieu - CHU Nantes — Nantes, France
Assistance Publique-Hopitaux de Paris (AP-HP) — Paris, France
Charité - Universitätsmedizin Berlin — Berlin, Germany
Cologne-Merheim Hospital Lung Clinic — Cologne, Germany
Universitaetsklinikum Giessen und Marburg GmbH — Giessen, Germany
Hospital Universitari Vall d'Hebron — Barcelona, Spain
Hospital Doctor Josep Trueta — Girona, Spain
Hospital Clinico San Carlos — Madrid, Spain
Hospital Universitari i Politecnic La Fe de Valencia — Valencia, Spain
University Hospital Bristol and Weston NHS — Bristol, United Kingdom
University Hospital of Wales — Cardiff, United Kingdom
Liverpool University Hospitals NHS Foundation Trust — Liverpool, United Kingdom
University College London — London, United Kingdom
University Hospitals Plymouth NHS Trust, Derriford Hospital — Plymouth, United Kingdom
Royal Berkshire Foundation Trust — Reading, United Kingdom

Full record on ClinicalTrials.gov

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